Last update June 14, 2022

Clozapine

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Dibenzodiazepine derivative. Atypical or second-generation antipsychotic with sedative properties. Indicated in the treatment of resistant schizophrenia and with risk of suicide. Oral administration in one or two daily doses.

It is excreted in breast milk in clinically insignificant amounts. (Barnas 1994)

No problems have been observed in infants whose mothers have taken it. (Uguz 2020, Uygur 2019)

One child, whose mother had taken clozapine during lactation, but also during pregnancy, had delayed speech acquisition until the age of 5 years. (Mendhekar 2007)

Clozapine has little or no significant effect on prolactin levels (Carvalho 2011). A case of galactorrhea with clozapine has been published, but in conjunction with taking other drugs. (Conca 2005)

The latest epidemiological studies on the appearance of agranulocytosis suggest that the incidence is low, much lower than was thought a few decades ago. (Ribé 2021, Pons 2012)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable(LactMed, Uguz 2021, McAllister 2017, Grover 2015, Parikh 2014, Klinger 2013), especially during the neonatal period and in the event of prematurity.


See below the information of this related product:

Alternatives

  • Olanzapine (Safe substance and/or breastfeeding is the best option.)
  • Quetiapine Fumarate (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.
DONATE NOW

Other names

Clozapine in other languages or writings:

Groups

Clozapine belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Clozapine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 327 daltons
Protein Binding 97 %
VD 1.6 l/Kg
pKa 15.9 -
Tmax 2.5 hours
T½ 8 (4 - 12) hours
M/P ratio 2.8 - 4.3 -
Theoretical Dose 0.01 - 0.02 mg/Kg/d
Relative Dose 1 - 1.5 %
Ped.Relat.Dose 0.3 - 2 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Ribé Buitrón JM, González Rodríguez M, Barceló Colomer ME. [Clozapine and agranulocytosis: Rethinking the usefulness of its monitoring]. Aten Primaria. 2021 Oct;53(8):102114. Abstract
  3. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  4. Uguz F. The use of clozapine during pregnancy and lactation: A case report. Psychiat Clin Psychopharmacol. 2020;30:193–5 Full text (link to original source)
  5. Uygur OF, Uygur H. Neurodevelopmental and growth follow-up of the baby exposed to antipsychotics during pregnancy and lactation: A case report. Psychiat Clin Psychopharmacol. 2019;29:744–7. DOI: 10.1080/24750573.2019.1627695 Full text (link to original source)
  6. McAllister-Williams RH, Baldwin DS, Cantwell R, Easter A, Gilvarry E, Glover V, Green L, Gregoire A, Howard LM, Jones I, Khalifeh H, Lingford-Hughes A, McDonald E, Micali N, Pariante CM, Peters L, Roberts A, Smith NC, Taylor D, Wieck A, Yates LM, Young AH; et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017 May;31(5):519-552. Abstract
  7. Grover S, Avasthi A. Mood stabilizers in pregnancy and lactation. Indian J Psychiatry. 2015 Abstract Full text (link to original source) Full text (in our servers)
  8. Parikh T, Goyal D, Scarff JR, Lippmann S. Antipsychotic drugs and safety concerns for breast-feeding infants. South Med J. 2014 Abstract
  9. Klinger G, Stahl B, Fusar-Poli P, Merlob P. Antipsychotic drugs and breastfeeding. Pediatr Endocrinol Rev. 2013 Mar-Apr;10(3):308-17. Review. Abstract
  10. Pons A, Undurraga J, Batalla A, Bernardo M. [Clozapine and agranulocitosis in Spain: do we have a safer population? A 5-year hematologic follow-up]. Rev Psiquiatr Salud Ment. 2012 Jan-Mar;5(1):37-42. Abstract
  11. Carvalho MM, Góis C. [Hyperprolactinemia in mentally ill patients]. Acta Med Port. 2011 Abstract
  12. Mendhekar DN. Possible delayed speech acquisition with clozapine therapy during pregnancy and lactation. J Neuropsychiatry Clin Neurosci. 2007 Spring;19(2):196-7. No abstract available. Abstract
  13. Conca A, Waler M, Walpoth M, König P, Hausmann A. A case of delayed galactorrhoea as an adverse event of overlapping haloperidol and clozapine administration. Int J Neuropsychopharmacol. 2005 Jun;8(2):303-5. No abstract available. Abstract
  14. Barnas C, Bergant A, Hummer M, Saria A, Fleischhacker WW. Clozapine concentrations in maternal and fetal plasma, amniotic fluid, and breast milk. Am J Psychiatry. 1994 Jun;151(6):945. No abstract available. Abstract

Total visits

14,223

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2015 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM